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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  05/14/2015
 
Trade Name:  IXINITY
 
Generic Name or Proper Name (*):  Coagulation Factor IX (Recombinant)*
 
Indications Studied:  Indicated in adults and children equal to or greater than 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Cangene Corporation
 
NNPS:  FALSE
 
Therapeutic Category:  Antihemophilic Factor
 
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